Kornimate/medical-research-clean huggingface dataset:
effectiveness of neuronavigated continuous theta burst stimulation of the left heschl's gyrus in chronic tinnitus

Conditions: Chronic Tinnitus

Summary: neuronavigated continuous theta burst stimulation of the left heschl's gyrus is used to modulate auditory cortex activity and plasticity contributing to the perception and distress of chronic tinnitus.

tinnitus is the phantom auditory perception of sound in the absence of an external or internal acoustic stimulus. it is a frequent problem which can interfere significantly with the ability to lead a normal life. one significant modulator of tinnitus is stress. tinnitus has been shown to be generated in the brain, as a result of functional reorganization of auditory neural pathways and the central auditory system. repetitive transcranial magnetic stimulation (rtms) is also effective in treatment of tinnitus with moderate effect size. pilot data were positive for low-frequency rtms applied to the temporal and temporoparietal areas. continuous theta burst stimulation (ctbs) is a new protocol of rtms with a possible superior effect in contrast to low-frequency rtms. also anatomical neuronavigation might increase the efficacy of rtms due to exact targeting of the primary auditory cortex. thus, the aim of this study is the evaluation of the clinical efficacy of neuronavigated left-sided ctbs in chronic tinnitus in a randomised sham-controlled two-arm design.

Eligibility criteria:
inclusion criteria: * diagnosis of bothersome, subjective chronic tinnitus * duration of tinnitus more than 6 months exclusion criteria: * objective tinnitus * treatable cause of the tinnitus * involvement in other treatments for tinnitus at the same time * clinically relevant psychiatric comorbidity * clinically relevant unstable internal or neurological comorbidity * history of or evidence of significant brain malformation or neoplasm, head injury * cerebral vascular events * neurodegenerative disorder affecting the brain or prior brain surgery * metal objects in and around body that can not be removed * pregnancy * alcohol or drug abuse * acute or chronic inflammation of the middle ear, meniere diseases, sudden idiopathic hearing loss, fluctuating hearing * history of seizures
study of sar97276a in the treatment of uncomplicated and severe malaria in adults and children.

Conditions: Malaria

Summary: the objective of the study is to assess the efficacy and safety of sar97276a in severe malaria in pediatric patients. before treating pediatric patients with severe malaria, the efficacy and safety of sar97276a will be first tested in adult patients, then in pediatric patients, with uncomplicated malaria. the safety and the concentration of sar97276a in blood and plasma will be assessed in adult and pediatric patients.

the treatment will be administered by intramuscular or intravenous route depending on the cohort. the treatment will be administered as single dose or 3-day repeated dose. the patients will be hospitalized for 3 days and followed up to 28 days following study treatment.

Eligibility criteria:
inclusion criteria: * adult patients with uncomplicated malaria will be enrolled in cohort 1 * pediatric patients with uncomplicated malaria will be enrolled in cohort 2 * pediatric patients with severe malaria will be enrolled in cohort 3 * plasmodium falciparum malaria confirmed in blood smear * fever within the last 24 hours. exclusion criteria: * treatment with an antimalarial agent within 72h of screening * severe concomitant disease * pregnant or breast-feeding women * women of child bearing potential not protected by an effective method of birth control the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Keywords: uncomplicated severe treatment plasmodium falciparum
artemisinin to reduce the symptoms of schizophrenia

Conditions: Schizophrenia; Schizoaffective Disorder

Summary: the investigators intend to explore the hypothesis that symptoms of schizophrenia may be reduced by the antimalarial compound artemisinin when used in addition to standard antipsychotic medications.

the aims of the current study are: 1. to evaluate the efficacy and side effects of artemisinin as an add-on compound for patients with schizophrenia who have residual psychotic symptoms of at least moderate severity. 2. to evaluate the effect of artemisinin on cognitive impairments and associated functional skills. 3. to investigate whether treatment with artemisinin produces a significant effect on the levels of antibodies to toxoplasma. 4. to examine whether changes in cognitive impairment or psychiatric symptoms are correlated with changes in antibodies to toxoplasma before and during the treatment with artemisinin.

Eligibility criteria:
inclusion criteria * age 18-65 years old. * capacity for written informed consent. * primary axis i diagnosis (dsm-iv) of schizophrenia, any type, or schizoaffective disorder (apa, 1994). * currently an outpatient at the time of enrollment. * residual psychotic symptoms which are at least moderately severe as evidenced by one or more positive and negative syndrome scale (panss) positive symptom scores, and/or panss negative symptom scores of 4 or more; or a total panss score of 50 or more, containing at least three positive or negative items with scores of 3 or more at screening. * conformance to patient outcome research team (port) treatment recommendation #5, maintenance antipsychotic medication dose (lehman et al., 2004). * receiving antipsychotic medication for at least 8 weeks prior to starting the study with no medication changes within the previous 21 days. * participants must be proficient in english. exclusion criteria * diagnosis of mental retardation. * history of iv drug use. * any serious medical condition that affects brain or cognitive functioning (e.g., epilepsy, serious head injury, brain tumor or other neurological disorder). * hiv infection or other immunodeficiency condition. * primary diagnosis of substance abuse or dependence according to dsm-iv criteria within the last three months. * participated in any investigational drug trial in the past 30 days. * pregnancy or planning to become pregnant during the study period. * any clinically significant or unstable medical disorder as determined by the investigators that would preclude study participation, including congestive heart failure, abnormal liver function or disease, renal failure, and any diagnosis of cancer undergoing active treatment.
a phase i study of ign523 in subjects with relapsed or refractory aml

Conditions: Acute Myelogenous Leukemia; Acute Myeloid Leukemia

Summary: this study will examine the safety and tolerability of ign523 administered as an iv infusion. the main purpose of the study is to determine the maximum tolerated dose (mtd), which is the highest dose that does not cause unacceptable side effects of ign523 in patients with acute myeloid leukemia (aml). the mtd will be determined by observing the dose-limiting toxicities (the side effects that prevent further increases in dose) of ign523. in addition, the pharmacokinetic profile and anti-leukemia activity of ign523 will be assessed. a recommended phase 2 dose (rp2d) of ign523 will be identified, on the basis of safety, pharmacokinetic (pk), and pharmacodynamic (pd) data.

primary objectives: * evaluate the safety and tolerability of ign523 administered weekly * determine the mtd and dose limiting toxicity (dlt) of ign523 when administered weekly during the dlt evaluation period * identify a recommended phase 2 dose (rp2d) of ign523 on the basis of safety, pk, and pd data secondary objectives: * assess the incidence of antibody formation to ign523 * characterize the pk of ign523 in subjects with relapsed or refractory aml * perform a preliminary assessment of the anti-leukemic activity of ign523 in subjects with relapsed or refractory aml * perform a preliminary assessment of biologic markers that might predict ign523 anti-leukemic activity estimated enrollment: 50 study start date: february 2014 estimated study completion date: march 2016 estimated primary completion date: september 2015 (final data collection for primary outcome measure)

Eligibility criteria:
inclusion criteria: * relapsed or treatment-refractory aml * eastern cooperative oncology group status 0-2 * life expectancy of at least 12 weeks * adequate baseline renal and hepatic function * measurable disease (eg, peripheral blasts greater than 5%) exclusion criteria: * chronic myelogenous leukemia in blast crisis * monoclonal therapy within 4 weeks, or chemotherapy or radiotherapy within 2 weeks * unresolved acute toxicity from prior anti-cancer therapy * prior allogeneic stem cell transplant and active graft-versus-host disease requiring systemic immunosuppressive therapy within 15 days prior to screening * history of severe allergic or anaphylactic reactions to monoclonal antibody therapy * known current leptomeningeal or central nervous system (cns) involvement of leukemia

Keywords: acute myelogenous leukemia acute myeloid leukemia drug therapy cd98 relapsed refractory monoclonal antibody
renal cancer monitoring based on ctdna methylomics: a prospective cohort study (memory study)

Conditions: Carcinoma; Renal Cell Carcinoma; RCC; Kidney Neoplasms; Kidney Cancer

Summary: to conduct prospective studies to confirm the value of circulating tumor dna and its abnormal methylation in longitudinal monitoring of patients undergoing kidney cancer surgery.

some studies have shown the potential of ctdna in renal cancer monitoring, but the amount of ctdna released in renal cancer is the lowest among non-cranial tumors. even in advanced patients, the detection rate of tumor system mutation is less than 50%. dna methylation is important in the process of tumor occurrence and development. however, no studies have focused on the value of ctdna methylation in monitoring renal cancer, nor have large prospective cohort studies been conducted in patients with renal cancer. this study intended to analyze the dynamic changes of circulating tumor dna and its methylation status in patients with kidney cancer from preoperative to long-term follow-up, and to compare the evaluation value of methylation detection with traditional imaging examination and traditional blood tumor markers in the monitoring process.

Eligibility criteria:
inclusion criteria: * newly diagnosed renal cell carcinoma * without any treatment * agree and accept radical surgical treatment * signed written informed consent * ecog(eastern cooperative oncology group) performance is 0 or 1 * follow up protocol and related procedures exclusion criteria: * had other cancers * had received any antitumor therapy before * known or suspected active autoimmune disease * informed consent is not possible due to medical or psychiatric problems * have clinical symptoms or diseases of the heart that are not well controlled * patients judged by the investigators to be unsuitable for inclusion in this study
real world effectiveness of abatacept in rheumatoid arthritis patients: a prospective, single-arm, open-label, multi-center observational study in taiwan

Conditions: Rheumatoid Arthritis

Summary: abatacept registry in taiwan


Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * ≥ 20 years of age * who give informed consent * confirmed diagnosis of ra (as defined by american college of rheumatology revised 1987 criteria) and has ≥ 4 of the criteria listed below for ≥6 weeks before study enrollment * who self-pay or who are reimbursed by bnhi for abatacept treatment * with latent tb or who are receiving anti-tb treatment (inh 300 mg, qd) 1 month prior to using abatacept and continuously up to a total of 9 months willing to follow taiwan risk management plan guidelines as required by taiwan health authorities * are being treated with abatacept or are abatacept treatment naïve and are initiating abatacept therapy exclusion criteria: * pregnant or breast feeding * with active tb * hbsag (+)and/or anti-hcv(+) and/or hbv dna(+) * have cancer (patients who were treated and have no sign of cancer for \> 10 years can be included) * are allergic to abatacept * enrolled in other ra clinical studies
ect/succinylcholine: biochemical, serum and cardiovascular changes

Conditions: Depression

Summary: this study will be conducted to determine the pharmacodynamics, cardiovascular and biochemical effects of succinylcholine when given during electroconvulsive therapy. (ect). this is a single center, prospective, study in patients who will be receiving ect as indicated and prescribed by their psychiatrist. the study will be performed twice on each patient, 48-72 hours apart during consecutively scheduled ect procedures.

patients will receive the anesthetic that is traditionally given which includes appropriate doses of succinylcholine. serum potassium and creatinine phosphokinase (ck) levels will be determined pre and post anesthesia; serum and urine myoglobin will be determined post anesthesia. vital signs data \[i.e., heart rate (arrhythmias) and arterial blood pressure\] will be compared pre and post anesthesia. in addition patients will be asked about the presence of muscle pain (myalgia) 1 hour before discharge from the recovery room and the following day post ect.

Eligibility criteria:
inclusion criteria: 1. a male or non-pregnant female aged 18 years and older 2. american society of anesthesiologists physical status 1, 2, 3 3. scheduled to undergo electroconvulsive therapy under general anesthesia 4. have given written informed consent exclusion criteria: 1. pregnant or nursing 2. any patient in the study investigators opinion who may not be suitable for research.
long-term safety and performance of the argos-sc suprachoroidal pressure sensor system in patients with glaucoma underwent non-penetrating glaucoma surgery

Conditions: Glaucoma; Open Angle Glaucoma

Summary: the purpose of this study is to evaluate the long-term safety and performance of the argos-sc system.

this study is designed as a prospective, open-label, multicenter, single-arm clinical investigation. this study is a follow-up study to the argos-sc01 study (nct03756662). patients who have graduated the argos-sc01 study after 12 month follow-up will be asked to enroll in this study for an additional 24 month follow-up (month 12-36 post implantation). this study will be solely observational, as only patients who had implanted the device within the earlier study will be invited to join this argos-sc01_fu study. the sensor was always implanted in one eye only which will be the study eye.

Eligibility criteria:
inclusion criteria: - subjects of the argos-sc01 study with an implanted argos-sc suprachoroidal pressure sensor. exclusion criteria: * n/a

Keywords: non-penetrating glaucoma surgery open angle glaucoma intraocular pressure measurements suprachoroidal pressure sensor argos-sc
transcranial magnetic stimulation to measure cortical excitability in dravet syndrome

Conditions: Dravet Syndrome

Summary: dravet syndrome (ds) is an epileptic encephalopathy caused by pathogenic variants in the scn1a gene resulting in medically refractory epilepsy and psychomotor delays. as a pilot study assessing for feasibility, the investigators aim to test whether alterations in cortical excitatory:inhibitory ratio can be reliably recorded. the investigators will utilize transcranial magnetic stimulation (tms) metrics of cortical excitatory and inhibitory tone as an initial step towards translating findings from rodent genetic models of ds into disease-specific biomarkers and offer future measures of therapeutic target engagement in this patient population. participants will complete two visits, each consisting of a tms session and an eeg session. visits will be scheduled 4-8 weeks apart.

this is a single site study to be conducted at boston children's hospital (bch) investigating the neurophysiological biomarkers of epilepsy and developmental disability in children and young adults with dravet syndrome. mechanistically, the features of the ds phenotype are attributable to a loss of cortical inhibition. tms is a non-invasive form of focal cortical stimulation in which an external powerful magnet induces an electrical field intracranially over the stimulated region that is used to interrogate or modulate states of cortical excitation or inhibition. accordingly, the investigators propose to test whether metrics of cortical excitability and inhibition can be obtained by transcranial magnetic stimulation (tms) and eeg in patients with ds.

Eligibility criteria:
inclusion criteria: * age: 6 months - 30 years * ability to obtain informed consent with the participant or legally authorized representative * ds confirmed by pathogenic variant in scn1a gene * medical history consistent with clinical phenotype of ds exclusion criteria: * comorbid conditions such as a second genetic diagnosis which may confound interpretation. * current or planned participation in a clinical drug or device trial. * previous participation in a gene therapy or gene editing trial * allergy to adhesives used for surface emg electrodes * contraindications to tms (e.g. implanted devices for which there is no tms safety data)
long-term efficacy, safety and tolerability of acz885 in patients with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: this study will assess the long-term safety and tolerability of acz885 in patients with rheumatoid arthritis, as well as long-term efficacy, long-term preservation and/or improvement of joint structure and bone mineral density, and long term maintenance of health-related quality of life.


Eligibility criteria:
inclusion criteria: * patients (male and non-pregnant, non-lactating females) who completed the core cacz885a2204, cacz885a2206, or cacz885a2207 study without serious or severe drug-related adverse effects may enter the extension study upon signing informed consent exclusion criteria: * patients for whom continued treatment in the extension is not considered appropriate by the treating physician. * patients who were non-compliant or who demonstrated a major protocol violation in the core study. * patients who did not complete / discontinued from the core study. * patients with drug related serious adverse events or severe adverse events. other protocol-defined inclusion/exclusion criteria may apply.

Keywords: rheumatoid arthritis anti-interleukin-1 beta acz885
a study of hyml-122 in patients with flt3 positive relapsed or refractory acute myeloid leukemia (aml)

Conditions: Relapsed or Refractory Acute Myeloid Leukemia (AML)

Summary: this is a single-arm, open, multicenter, phase 2 study to evaluate the efficacy, safety and pharmacokinetics of hylm-122 monotherapy in chinese subjects with flt3 positive relapsed or refractory acute myeloid leukemia.


Eligibility criteria:
inclusion criteria: * fully understand the procedures of the clinical study and participate voluntarily with signed and dated written informed consent form, comply with the requirements of the study protocol. * males and/or females at least 18 years old when signing the informed consent form. * histologically confirmed aml (defined using who criteria 2016) with one of the following: refractory to at least 1 cycle of induction chemotherapy. relapsed after achieving remission with a prior therapy. * subject is positive for flt3 mutation in bone marrow or blood after completion of the subject's last interventional treatment. * eastern cooperative oncology group performance status (ecog) ≤2 at screening. * life expectancy of at least 3 months. * women of childbearing potential have a negative pregnancy test at baseline and are willing to employ an effective method of contraception for the entire duration of study treatment and 6 months after the last dose. exclusion criteria: * known or suspected allergies to any of the investigational drug composition (hyml-122, lactose, hydroxypropyl cellulose, hyposubstituted hydroxypropyl cellulose, silicon dioxide, magnesium stearate, titanium dioxide and polyethylene glycol). * medical history and surgical history excluded according to the protocol. * any previous medical treatment history exclude from the protocol. * abnormal laboratory results exclude from the protocol. * combination of treatments and/or drugs required during the study period and cannot be discontinued that excluded from the protocol. * alcohol abuse within 6 months prior to screening, defined as long-term drinking history, generally more than 5 years, equivalent to alcohol quantity ≥40g/d for men, ≥20g/d for women, or heavy drinking history within 2 weeks, equivalent to alcohol quantity ≥80g/d. alcohol volume (g) conversion formula=alcohol consumption (ml)\*alcohol content (%)\*0.8. * abortion less than 30 days prior to screening, pregnant and lactating women (currently breast-feeding or less than one year after delivery although not breast-feeding), women of childbearing potential who are not guaranteed effective contraception during the study, planning pregnancy or donating eggs or sperm within 6 months after the last dose. * history of drug abuse or drug addicts. * subjects may not be able to complete the study duo to poor compliance or other reasons, or unsuitable for the study by the investigator's judgment.
the vancouver-bold study: the burden of chronic obstructive lung disease

Conditions: Chronic Obstructive Lung Disease

Summary: this is a study of the lung health of the population of vancouver and the extent of, and the risk factors for, chronic obstructive lung disease.


Eligibility criteria:
inclusion criteria: * 40 years of age and older * both sexes * random sample of population exclusion criteria: * contraindication for lung function testing and serious life threatening illness.

Keywords: epidemiology lung health lung function copd